
10,000+ employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
đ July 16
đŁď¸đŠđŞ German Required
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10,000+ employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
⢠Perform site management activities in compliance with Company and Sponsor SOPs and Work Instructions ⢠Assure compliance with local regulations, GPP, and ICH-GCP as applicable ⢠Conduct site identification, site qualification, and site start-up activities ⢠Conduct remote and on-site monitoring activities through all study stages ⢠Review Investigator Site Files for accuracy, timeliness, and completeness and reconcile them with Trial Master Files ⢠Ensure investigator sites understand essential-document archiving requirements ⢠Document activities through confirmation letters, follow-up letters, trip reports, communication logs, and other project documents ⢠Support subject/patient recruitment, retention, and awareness strategies ⢠Track observations, site status, and action items through resolution ⢠Protect subject/patient confidentiality ⢠Review assigned-site data, assist with query resolution and missing-data follow-up, and use data trend reports ⢠Maintain timely communication with site staff and project teams and escalate issues appropriately ⢠Maintain clinical tracking and management systems ⢠Ensure sites are trained and compliant with study protocols, informed consent, data collection, and safety reporting ⢠Support audit readiness, audit preparation, and follow-up actions ⢠Attend and participate in Investigator Meetings and sponsor meetings ⢠Collaborate with Sponsor affiliates, medical science liaisons, and local country sponsor staff ⢠Manage site-level activities, communication, deliverables, budgets, and timelines ⢠Identify and communicate out-of-scope activities ⢠Attend, contribute to, and present at study and department meetings
⢠Required - German Language - written and spoken ⢠Minimum 1 year relevant onsite monitoring experience required ⢠BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience ⢠Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint), email/voicemail, and Clinical Trial Management and EDC systems ⢠Previous site management (in-house, on-site, Study Coordinator) or equivalent experience ⢠Excellent communication, time management, organizational, documentation and customer service skills ⢠Knowledge of local requirements for Real World Late Phase study designs, Real World Research, and relevant regulations including GPP ⢠Excellent customer focus and ability to interact professionally with a client organization and study site ⢠Willingness to work within a team-oriented environment ⢠Ability to work in a virtual team setting and independently, seeking guidance as appropriate ⢠Ability to handle multiple tasks and prioritize to achieve study timelines ⢠Sound problem solving and analytical skills ⢠Excellent command of written and spoken local language, if not English, as well as English required ⢠Ability to develop good working relationships via oral communication and good phone etiquette ⢠Ability to travel up to 60% on a regular basis depending on assignments and study phase
⢠Career development and progression ⢠Supportive and engaged line management ⢠Technical and therapeutic area training ⢠Peer recognition ⢠Total rewards program ⢠Inclusive culture ⢠Reasonable accommodations when appropriate
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